A randomized phase II study of pleurectomy/decortication preceded or followed by (neo-)adjuvant chemotherapy in patients with early stage malignant pleural mesothelioma (EORTC 1205)

Abstract

Radical multimodality treatment for malignant pleural mesothelioma (MPM) is controversial, with intense debate (but lack of data) about which surgical procedure to perform [extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD)], if any. In order to perform a randomized comparison, the most optimal sequence of surgery and chemotherapy should be determined. EORTC 1205 is a clinical trial randomizing between upfront surgery, followed by chemotherapy (cisplatin plus pemetrexed) and deferred surgery, following neoadjuvant chemotherapy in early stage (T1–3 N0–2 M0) MPM (irrespective of histological subtype). The surgical procedure performed is (extended) pleurectomy/decortication (e-PD), which is promoted as an alternative for EPP, but lacks standardization. Primary outcome parameter is successful completion of multimodality treatment; secondary outcome parameters are surgical quality parameters (in order to standardize the procedure), progression free survival (PFS) and overall survival (OS), treatment-failure free survival, operative morbidity and mortality, toxicity and safety.